Sr. GMP Engineering Technician - Marcus Center for Cellular Cures

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Duke University’s Marcus Center for Cellular Cures (MC3) has immediate openings for a Sr. GMP Engineering Technician in our GMP Manufacturing Laboratory.

Our Vision: To live in a world where every person has access to high quality and effective cell based therapies

Our Mission: Together we design, develop and deliver the highest quality cellular therapies to improve health

More information is available at the following link:  https://marcuscenter.duke.edu/

 

Occupational Summary

The incumbent in this position is responsible for highly complex and specialized manufacturing of cellular products for clinical trials and commercial operations. Alternatively, this individual will be responsible for supporting the daily engineering and facility operation of the GMP facility to ensure it is in control and in compliance with applicable regulations. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical material for novel cellular therapies.

Work Performed

Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guideline. Following standard operating procedures, conduct facility and engineering operation and maintenance under GMP (GLP, GTP, GMP, GDP) guidelines.

Utilize metrology techniques to calibrate equipment parameters such as temperature, pressure, mass, humidity and pressure for controlled units such as refrigerator, freezers, and incubators. Maintain, troubleshoot, and repair/upgrade all Critical Systems Controls, equipment work orders, PM and calibration schedules. Conduct balance scale check and verification for the facility. Provide documentation to support measurements. Work with user teams to ensure tracking systems are working properly and provide accurate information.

Perform calibration utilizing metrology methods for Isensix environmental monitoring system. Perform repair and system administrator services to the Isensix environmental monitoring system including access point, collection point and sensor replacement.

Communicate changes to GMP Lab staff.  Support personnel that come on site for equipment repairs or calibration (assist them with facility access and supervise gowning in). Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc). Coordinate and schedule calibration activities with laboratory and manufacturing departments to meet deadlines.

Assists with tasks for engineering department and manufacturing such as repairs, scheduling and shadowing vendors and contacting manufacturers for support. Manage spare parts and portable equipment inventory.  

Apply Good Documentation Practices (GDP) for all records, adhering to SOPs, and verification to ensure compliance. Performs and documents all activities as outlined in all SOP and GMP guidelines.

Give guidance on cell manufacturing instrumentation operation including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, and Biological Safety Cabinets and CO2 gas system.

Accurately complete and review metrology documentation, all appropriate equipment log entries, and GMP documentation. Write and review validations, research plans and reports, SOPs, and batch records as required.

Maintain equipment calibration schedules and lab space, coordinating with contractors where required.

Work with Lab manager and quality assurance colleagues to ensure the facility is in compliance with governing regulations.

Participate in lab inspections and work with inspectors as needed.

Maintain sufficient inventory of supplies and reagents for performance of duties.

Provide guidance on and participate in cleaning and maintenance on laboratory equipment in good working order